GlaxoSmithKline ((GSK)), GlaxoSmithKline plc (UK) ((GB:GSK)), Iteos Therapeutics, Inc. ((ITOS)) announced an update on their ongoing clinical study.
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GlaxoSmithKline (GSK) and Iteos Therapeutics are conducting a Phase 3 clinical study titled ‘GALAXIES Lung-301’ to assess the safety and efficacy of belrestotug combined with dostarlimab versus pembrolizumab with placebo in patients with high PD-L1 non-small-cell lung cancer (NSCLC). The study aims to determine if the new combination improves progression-free survival and overall survival compared to the standard treatment.
The interventions being tested include the biological agents dostarlimab and belrestotug, intended to treat NSCLC by targeting specific cancer pathways. Pembrolizumab, a well-known cancer therapy, serves as the active comparator with a placebo.
This randomized, double-blind study employs a parallel intervention model with quadruple masking, ensuring that participants, care providers, investigators, and outcomes assessors are unaware of the treatment allocations. The primary purpose is treatment-focused, aiming to provide new insights into NSCLC management.
The study commenced on June 10, 2024, with its primary completion and estimated overall completion dates yet to be announced. The latest update was submitted on July 14, 2025, indicating ongoing progress.
This study could significantly impact GSK’s and Iteos Therapeutics’ market positions, potentially boosting investor confidence if results show a positive outcome. As competition in the oncology sector intensifies, successful trial outcomes could enhance these companies’ competitive edge.
The study is currently active but not recruiting, with further updates available on the ClinicalTrials portal.